Exceptions to the rule of informed consent for research with an intervention
Exceptions to the rule of informed consent for research with an intervention
复制标题
DOI：
10.1186/s12910-016-0092-6
复制
发表时间：
2016-02-06
影响因子：
2.7
通讯作者：
Schmidt, Marjanka K.
中科院分区：
文献类型：
--
作者：
Rebers, Susanne;Aaronson, Neil K.;Schmidt, Marjanka K.
背景资料：在特定情况下，可能有必要对进行干预的科学研究的知情同意的一般规则作出例外规定。早期的评论只描述了子集的参数例外放弃consent.Methods：在这里，我们提供了一个更广泛的文献综述的可能例外的规则知情同意和相应的参数的基础上，从1997年起，使用Pubmed和PsycINFO在我们的搜索strategy.Results：我们确定了三个主要类别的参数的可接受性的同意放弃：数据的有效性和质量、主要的实际问题以及参与者的苦恼或困惑。必须获得医学伦理审查委员会的批准。此外，我们提供的具体条件下，同意放弃可能被允许的例子，如额外的隐私保护measurements.Conclusions：合法化的论文作者在此概述中的原因可以被研究人员用来形成自己的意见，要求一个例外的规则，知情同意为自己的研究。重要的是，应遵守适用于其国家、机构和研究领域的规则和准则。此外，研究人员还应该考虑他们认为例外合法化的条件。在与相关利益相关者讨论后，应向IRB发送正式请求。
Background: In specific situations it may be necessary to make an exception to the general rule of informed consent for scientific research with an intervention. Earlier reviews only described subsets of arguments for exceptions to waive consent.Methods: Here, we provide a more extensive literature review of possible exceptions to the rule of informed consent and the accompanying arguments based on literature from 1997 onwards, using both Pubmed and PsycINFO in our search strategy.Results: We identified three main categories of arguments for the acceptability of a consent waiver: data validity and quality, major practical problems, and distress or confusion of participants. Approval by a medical ethical review board always needs to be obtained. Further, we provide examples of specific conditions under which consent waiving might be allowed, such as additional privacy protection measures.Conclusions: The reasons legitimized by the authors of the papers in this overview can be used by researchers to form their own opinion about requesting an exception to the rule of informed consent for their own study. Importantly, rules and guidelines applicable in their country, institute and research field should be followed. Moreover, researchers should also take the conditions under which they feel an exception is legitimized under consideration. After discussions with relevant stakeholders, a formal request should be sent to an IRB.